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Ardelyx Announces Publication of Two Plain Language Summaries from XPHOZAH® (tenapanor) Clinical Trials in Current Medical Research and Opinion
ArdelyxArdelyx(US:ARDX) Newsfilter·2024-07-31 12:02

Core Insights - Ardelyx, Inc. has published plain language summaries of clinical trial results for XPHOZAH® (tenapanor), aimed at helping patients with chronic kidney disease (CKD) on dialysis understand safety and efficacy data [1][3] - XPHOZAH is the first and only phosphate absorption inhibitor approved by the FDA for reducing serum phosphorus in adults with CKD on dialysis [2][12] - The NORMALIZE and OPTIMIZE studies provide insights into the effectiveness of XPHOZAH in managing hyperphosphatemia in CKD patients [5][6][7] Company Overview - Ardelyx is focused on discovering, developing, and commercializing innovative medicines to address significant unmet medical needs [1][13] - The company has two commercial products approved in the U.S.: IBSRELA® and XPHOZAH® [13] Product Information - XPHOZAH works by blocking phosphate absorption in the gut, specifically targeting the sodium hydrogen exchanger 3 (NHE3) [4] - It is administered as a single tablet taken twice daily, with diarrhea being the most common side effect reported in clinical trials [4][11] Clinical Trials - The NORMALIZE study is an 18-month extension study evaluating the ability of XPHOZAH to maintain normal serum phosphate levels in patients with CKD on dialysis [5] - The OPTIMIZE study involved 330 patients and assessed different methods of initiating XPHOZAH for phosphorus management [6][7] Medical Context - Hyperphosphatemia is a prevalent condition among the 550,000 patients in the U.S. with CKD on maintenance dialysis, necessitating effective management strategies [8]